Senior Director, Bioanalysis
Core
Provide strategic leadership and end-to-end accountability for bioanalytical sciences across clinical and nonclinical development programs to support PK/PD evaluations.
Role type
Senior Director, Bioanalysis (Strategic IC)
Builds
Bioanalytical strategies and data for novel therapeutics (small molecules, siRNA, emerging platforms) targeting MASH
Domain
Biopharmaceuticals / Bioanalysis / MASH
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LC-MS/MS quantitative bioanalysis, bioanalytical assay development and validation, CRO partner management, regulatory compliance (FDA/EMA/ICH), cross-functional leadership
Preferred skills
Hybridization-based assays, ligand binding assays, immunoassays
Technologies
LC-MS/MS, CRO platforms
Responsibilities
Define and implement bioanalytical strategies across a portfolio of programs; Select, manage, and evaluate CRO partners; Develop scalable CRO partnering strategy including assay transfer and lifecycle management; Provide oversight of assay development, qualification, validation, and sample analysis; Ensure all bioanalytical activities meet global regulatory requirements; Review and approve bioanalytical documentation; Lead issue identification and resolution for CRO performance; Partner cross-functionally with Clinical Operations, Translational Medicine, and Regulatory; Contribute to and lead bioanalytical strategy for regulatory submissions; Represent the bioanalytical function externally
Seniority
Senior Director, strategic leadership & cross-functional influence
